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Microbiology and Infectious Diseases Resources

Vaccine Development Services

What services are provided?

The Vaccine Development Services is intended for use in the investigation, control, prevention, and treatment of a wide range of infectious agents other than HIV. The Vaccine Development Services supports the following products: vaccines, vaccine components including adjuvants, vaccine delivery systems, other biologics, and BSL-2, BSL-3, and BSL-4 challenge material.

The suite of services provided by the Vaccine Development Services includes:

Vaccine Testing Services

Assay Development for Non-Clinical and Clinical Samples

Non-Clinical Immunogenicity and Efficacy Studies

Clinical and Non-Clinical Sample Testing

Safety and Toxicity Testing

Vaccine Manufacturing Services

Feasibility, Gap Analysis, and Product Development Plan Support

Process Development

Product Release Assay Development including Potency Assays

Pilot and cGMP Manufacture

Audits

Regulatory Activities and Documentation

As appropriate, studies may be conducted in compliance with GLP (Good Laboratory Practice) and cGMP (Current Good Manufacturing Practice).

Note: Resources are limited and intended to fill critical gaps and are not to be the sole source of product development. Preliminary data to support program participation are required.